The Impact of an Adapted Version of the Strengthening Families Program on IPV Among Caregivers and ACEs Among Children

Domestic Violence Clinical Trial

Official title:

The Impact of an Adapted Version of the Strengthening Families Program on Reducing IPV Among Caregivers and ACEs Among Their Children (RCS Update)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129501
• Other study ID #: 21287
• Status: Completed
• Phase: N/A
• Start date: October 9, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: May 2023
• Source: University of Nebraska Lincoln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adverse childhood experiences (ACEs) are unfortunately common and the known outcomes are concerning. However, very little is currently know about programs that may prevent ACEs among children such as witnessing IPV experienced by their caregivers. The purpose of this project is to adapt an existing evidence-based program (i.e., Strengthening Families) to prevent ACEs. A randomized control will be used to determine the initial efficacy of the program. The Strengthening Families program has demonstrated effectiveness in reducing substance use and initiation among youth and some preliminary evidence suggests that it may be effective at reducing child maltreatment as well. Further, the Strengthening Families program promotes family bonding and cohesion, which are protective factors against ACEs. The Strengthening Families program has been adapted by researchers at UNL (Devan Crawford and Les Whitbeck) for Native American Families (i.e., BII-ZIN-DA-DE-DAH [Listening to One Another]) to prevent substance abuse. Using the Strengthening Families and BII-ZIN-DA-DE-DAH programs, the investigators seek to adapt these programs to prevent ACEs among youth ages 10-14 and their caregivers. The program adaptations are being led by a Community Advisory Board as well as community practitioner partners. The community has named the program Tiwahe Wicaghwicayapi (Lakota for: to strengthen/improve families). Native children and/or children living in poverty, ages 10 to 14, will participate in the program with their families. Half of the families will go first and then the second half of the families will get the program after the last survey. The investigators will use surveys to see if and how the program is working and also interview some people who go through the program. A community Advisory Board is involved in all stages of this project and have the ultimate say about how data are shared.

Description:

Research documents the concerning rates and negative outcomes of adverse childhood experiences (ACEs). ACEs include child abuse as well as indicators of household (e.g., exposure to intimate partner violence [IPV]) and neighborhood (e.g., community violence) dysfunction. To date, little is known about two-generation programs that may simultaneously prevent ACEs among children, including IPV in their caregivers.

The purpose of the proposed project is to test the impact of a widely researched alcohol and drug abuse prevention program, the Strengthening Families Program (SFP), on reducing IPV among caregivers, child abuse, and other ACEs among their children (ages 10 to 14). The SFP is for both caregivers and children and consists of parenting skills, children's life skills, and family skills courses taught together in seven 2-hour group sessions preceded by a meal that includes informal family practice time and group leader coaching. Guided by social learning and ecological theories that emphasize the importance of the proximal family environment, the members of this multistakeholder collaborative believe that the SFP has the strong potential to be effective in reducing IPV in caregivers and additional ACEs in their children (e.g., child abuse) given the SFP focuses on reducing myriad risk and protective factors for not only drug use but also for ACEs, including IPV.

To bolster the program's effectiveness, the investigators will adapt the SFP (the adapted program will be called Tiwahe Wicaghwicayapi, Lakota for "to strengthen/improve families") to be culturally relevant given the large presence of American Indians in Rapid City, SD, where the project will take place and to have utility for a broader, diverse audience. Notably, service providers in racially diverse communities frequently do not have the resources to implement various prevention programs. Thus, there is a need in many communities for ACEs prevention programming that is culturally grounded and generalizable to the broader community. The investigators will further enhance the Tiwahe Wicaghwicayapi program to include additional evidence-based IPV prevention strategies (e.g., economic empowerment) for adults and peer-to-peer violence prevention strategies (e.g., bystander intervention) for youth. Specific Aims are as follows:

Adaptation and Planning Aims (Year 1): Convene a Research and Practice Advisory Board that includes elders, practitioners, educators, youth, caregivers, and preventionists (Aim 1a), and conduct focus groups with diverse youth ages 10 to 14 (N = 10), caregivers (N = 10) and professionals (N = 10) in order to culturally tailor the SFP in addition to integrating the IPV prevention components (Aim 1b). Conduct an open pilot trial of the adapted program with 10 families (Aim 1c). Engage youth (N = 10) and caregivers (N = 10) in cognitive testing of survey instruments to be used in the subsequent clinical trial (Aim 1d).

Outcome and Process Evaluation Aims (Years 2 and 3): Following widespread community recruitment, implement and evaluate the feasibility and acceptability of the Tiwahe Wicaghwicayapi program with high-risk families (i.e., American Indian, low income) (Aim 2a). Conduct program observations and fidelity checks (Aim 2b). Gather efficacy data of the Tiwahe Wicaghwicayapi program using a randomized control trial in which eligible families will be randomly assigned to the treatment condition (N = 75 families enrolled) or a wait-list control condition (N = 75 families enrolled), using pre-, immediate post- and 8-month post- follow-up surveys to test for reductions in ACEs (e.g., child abuse) in youth ages 10 to 14 (N = 150 enrolled) and reductions in IPV in caregivers (N = 150 enrolled) for individuals in the treatment group compared to the wait-list control group (Aim 2c). Exploratory analyses will identify mediators (e.g., increases in adult supervision, economic empowerment) and moderators (e.g., gender) of program outcomes (Aim 2d). Conduct exit interview with youth (N = 10), caregivers (N = 10), and program facilitators (N = 10) to gather perceptions of program implementation and impact (Aim 2e). Engage a subset of families (N = 10 youth and N = 10 adults) post-intervention in Photovoice in order to document via photography and group discussions what family strengths look like with a specific focus on what they learned in Tiwahe Wicaghwicayapi program (Aim 2f).

Revision and Dissemination Aims (Year 3): Using data collected as part of Aims 2a to 2f, revise the program and training manuals in anticipation of widespread dissemination to other communities with a large presence of American Indians (Aim 3a). Disseminate the findings and lessons learned to diverse audiences (Aim 3b).

The project is highly significant given the high rates and deleterious outcomes of ACEs in youth including IPV in caregivers. The project is innovative in that the investigators will adapt, implement, and evaluate a highly promising, evidence-based program among a diverse group of high-risk families and use innovative evaluation methodologies (e.g., Photovoice). Finally, the project is feasible given its seasoned team of researchers and project partners, who have a highly successful history of previous collaborations and close attention paid to methodological and programmatic considerations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Youth must be aged 10 to 14

• Must identify as a Native American, American Indian, Indigenous, and/or Lakota/Nakota/Dakota youth AND/OR live in poverty

• For caregivers, the inclusion criteria is that they must be a primary caregiver (e.g., parent, grandparent, etc) of a youth that meets criteria

• Both the youth and the caregiver(s) must be present to participate

Exclusion Criteria:

• Youth younger than 10 or older than 14

• Not identifying as Native American, American Indian, indigenous, and/or Lakota/Nakota/Dakota youth OR living in poverty

• Not being a primary caregiver of a youth that meets criteria

• Not having both the caregiver and youth present

Related Conditions & MeSH terms

• Adverse Childhood Experiences
• Domestic Violence

Intervention

Behavioral:
• Experimental
The Tiwahe Wicagwicayapi seven-session program is for children ages 10 to 14 who are Native American and/or living in poverty and their caregivers. The program begins with a traditional Lakota meal followed by family time and break-out time for caregivers only and children only. The program includes skill-building activities as well as the integration of Lakota language, history, and culture. The program is facilitated by diverse individuals, predominantly Native Americans in Rapid City and surrounding tribal communities.

Locations

Country	Name	City	State
United States	Rapid City Family Project Office	Rapid City	South Dakota

Sponsors (3)

Lead Sponsor	Collaborator
University of Nebraska Lincoln	Bennington College, Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (5)

Kaufman, E. A., Xia, M., Fosco, G., Yaptangco, M., Skidmore, C. R., & Crowell, S. E. (2016). The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and replication in adolescent and adult samples. Journal of Psychopathology and Beha

Kumpfer, K. L. (1998). Prevention Interventions: The Strengthening Families Program. Drug Abuse Prevention Through Family Interventions, 160-207.

Olson, D. H., Portner, J., & Bell R. Q. (1982). FACES II: Family adaptability and cohesion evaluation scales. Family Social Science, University of Minnesota, St. Paul, Minnesota.

Small, S. A., & Kerns, D. (1993). Unwanted sexual activity among peers during early and middle adolescence: Incidence and risk factors. Journal of Marriage and the Family, 941-952.

Straus, M. A., Hamby, S. L., Boney-McCoy, S., & Sugarman, D. B. (1996). The revised conflict tactics scales (CTS2) development and preliminary psychometric data. Journal of family issues, 17(3), 283-316.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Family Cohesion	Family Adaptability and Cohesion Evaluation Scales II (Min:1, Max:5; Higher scores indicate more cohesion).	Past 6 months
Other	Parental Monitoring	Nine items adapted from Small & Kerns (1993). (Min:1, Max:5; Higher scores indicate more monitoring).	Past 6 months
Other	Emotion Regulation	Difficulties in Emotion Regulation Scale Short Form (Min:1, Max:5; Higher scores indicate less regulation)	Past 6 months
Other	Connection to Lakota/Nakota/Dakota Culture	Author created with community input (Min: 0, Max: 3; Higher scores indicate greater connection to Lakota/Nakota/Dakota culture)	Past 6 months
Primary	Adverse Childhood Experiences	Comprehensive ACEs Measure (Min: 0, Max: 1; Higher scores indicate higher adverse childhood experiences)	Past 6 months
Primary	Conflict Tactic Scale	Intimate Partner Violence (Min: 0, Max: 1; Higher scores indicate higher levels of intimate partner violence)	Past 6 months